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Generated: November 13, 2018

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Details for New Drug Application (NDA): 088911

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NDA 088911 describes BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, which is a drug marketed by Abraxis Pharm, Fresenius Kabi Usa, and Hospira, and is included in three NDAs. It is available from seven suppliers. Additional details are available on the BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER profile page.

The generic ingredient in BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is sodium chloride. There are one thousand four hundred and fifty-four drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the sodium chloride profile page.
Summary for 088911
Tradename:BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Applicant:Fresenius Kabi Usa
Ingredient:sodium chloride
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 088911
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER sodium chloride INJECTABLE;INJECTION 088911 ANDA APP Pharmaceuticals, LLC 63323-924 63323-924-10 25 VIAL, MULTI-DOSE in 1 TRAY (63323-924-10) > 10 mL in 1 VIAL, MULTI-DOSE
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER sodium chloride INJECTABLE;INJECTION 088911 ANDA APP Pharmaceuticals, LLC 63323-924 63323-924-30 25 VIAL, MULTI-DOSE in 1 TRAY (63323-924-30) > 30 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength9MG/ML
Approval Date:Feb 7, 1985TE:APRLD:No

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